Weekday Senior Process Engineer

Tableau Software•Spokane, WA

49d

About The Position

The Senior Process Engineer provides expertise primarily in the areas of pharmaceutical process engineering and technical transfer. This position will manage large scale projects and multi-disciplinary teams. The process engineer will also provide technical direction for complex projects and exhibit superior communication skills with all levels of employees. The individual will be responsible for refining department and site processes and provide leadership and guidance to others.

Responsibilities

Design, optimize and implement site manufacturing processes to improve efficiency, quality and sustainability
Oversee and assess existing processes and workflows
Establish and track process metrics to monitor process stability and discover areas for improvement
Technical Transfer of new products from both internal and external clients
Ownership of product process from initial quote to product retirement
Evaluate incoming processes for robustness, efficiency and fit within JHS-Spokane
Perform appropriate development work to define CPPs and CQAs to allow strong execution upon transfer to Manufacturing.
Author validation study documents that demonstrate manufacturing processes are capable of consistently making acceptable product.
Develop and execute validation studies to test and qualify new and improved manufacturing processes.
Troubleshooting, oversight and/or sampling of events within Manufacturing will require occasional off-shift at-location support.
Generate reports summarizing results of studies to document data collected; utilize data obtained to qualify site processes
Review data summaries generated by other departments, assess the data for potential trends or conditions that may adversely impact the quality of the sterile products being manufactured, and ensure that corrective action measures are implemented when required/warranted.
Participate in or perform deviation investigation and evaluation of impact
Implement effective CAPAs
Responsible for optimizing gross profit margin and minimizing deviation rate
Provide necessary reviews for regulatory and client audits and provide responses to audit observations
In-depth understanding of cGMP's, European regulatory requirements, relevant USP chapters, and scientific principles associated with clean room operations and room classifications as they apply to media fills, sterilization and depyrogenation (dry heat and steam), endotoxin reduction, and microbiological monitoring and control.